BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3243640 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12201
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7438 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V331504, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V329593, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENCEPHALOPATHY IN 2011. IT WAS STATED THERE WAS IN INCREASE IN WHITE BLOOD CELLS AND THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED, THE PATIENT EXPERIENCED BEING ¿VERY SLEEPY.¿ THE PATIENT WAS ADMITTED TO THE HOSPITAL AND SYMPTOMS STOPPED AFTER THREE DAYS THEN THE PATIENT WAS BACK TO BASELINE. REFERENCE REG REPORT # 3004209178-2013-12198

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343346 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| R